Speaker
Summary
Actinium-225 from a variety of production methods is becoming more widely available.
As more and diverse suppliers enter, or intend to enter, the Ac-225 active pharmaceutical ingredient (API) market, the greater the need for demonstrating adequate quantitation of radionuclidic impurities. Regulatory implications for Ac-227 in the USA include; a mandatory spill reporting limit of only 2 nCi, financial assurance requirements for possession over 10 µCi, and an annual limit on intake (ALI) of only 0.4 nCi (Shober, 2022). Some EU member countries have indicated that a separation factor of at least 108 (Ac-227 / Ac-225) may be required. Similarly stringent requirements also exist for a variety of other important potential impurities including; Ra-226, Po-210, and Th-229. The importance of individual patient dosimetry cannot be understated, and high-purity Ac-225 aids in these calculations. Standardization of certificates of analysis (CofA) within the industry may not be achievable, however, suppliers and customers can coalesce around the idea of demonstrating the highest possible standards for radionuclidic purity (RNP).
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